Timing of Coronary Angiography in NSTEMI Complicated by Acute HF

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorChonnam National University Hospital

About this trial

Study objectives:

To determine the optimal timing of coronary angiography (CAG) in patients with non-ST-segment elevation myocardial infarction (NSTEMI) complicated by acute decompensated heart failure (AHF). The primary objective of this trial is to test the hypothesis that immediate CAG ≤2 hours after establishment of NSTEMI diagnosis would result in a significant reduction in primary composite outcome of death from any cause, non-fatal myocardial infarction (MI), or hospitalization for heart failure (HF) at 12 months after randomization as compared with delayed CAG after stabilization.

Study hypothesis:

Immediate CAG ≤2 hours after establishment of NSTEMI diagnosis would result in a significant reduction in primary composite outcome of death from any cause, non-fatal myocardial infarction (MI), or hospitalization for heart failure (HF) at 12 months after randomization as compared with delayed CAG after stabilization.

Background:

Although current guidelines recommend early CAG within 2 hours for patients with NSTEMI complicated by AHF, many patients with NSTEMI complicated by AHF did not receive early CAG. However, no randomized clinical trials have evaluated the optimal timing of CAG in patients with NSTEMI complicated by AHF. Therefore, the investigators aimed to perform a prospective, investigator-initiated, open-label, muilticenter trial to compare the efficacy and safety between immediate CAG (CAG \<2 hours after establishment of NSTEMI diagnosis) and delayed CAG after stabilization (i.e. improved dyspnea and disappearance of pulmonary congestion) in participants with NSTEMI complicated by AHF.

Study procedure:

Following the establishment of NSTEMI diagnosis, participants fulfilling the eligibility criteria will be randomized at a ratio of 1:1 to immediate CAG ≤2 hours after randomization or delayed CAG after stabilization on another day during hospitalization.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥19 years

Non-ST-segment elevation myocardial infarction

New-onset or worsening of dyspnea (New York Heart Association class ≥2)

Pulmonary congestion

Disqualifiers

Cardiogenic shock at initial presentation

ST-segment elevation myocardial infarction

ST-segment elevation ≥0.1 mV in at least 2 contiguous leads, or

New onset left bundle branch block

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immediate coronary angiography

    Procedure/Surgery

    Immediate coronary angiography ≤2 hours after randomization

  • Delayed coronary angiography

    Procedure/Surgery

    Delayed coronary angiography after stabilization

Treatment groups

780 Participants
are divided into 2 treatment groups
Group A: Immediate coronary angiography within 2 hours after diagnosis of non-ST-segment elevation myocardialExperimental treatment 1 intervention
Group B: Delayed coronary angiography after stabilization of acute decompensated heart failureActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

A cumulative incidence rate of all-cause death, non-fatal myocardial infarction (MI), or hospitalization for heart failure (HF)

Time frame
1 year

Secondary outcomes

1

A cumulative incidence rate of all-cause death, non-fatal MI, or hospitalization for HF

Time frame
1, 6, 24, 36 months
2

All-cause death

Time frame
1, 6, 12, 24, 36 months
3

Non-fatal MI

Time frame
1, 6, 12, 24, 36 months
4

Hospitalization for HF

Time frame
1, 6, 12, 24, 36 months

Other outcomes

Sponsors and contacts

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